Philips Medical Systems recalled 12 Allura Xper FD10F systems on December 15, 2025, after identifying a potential electrical hazard. The drip tray beneath the cooling unit may not have been installed correctly, posing a risk of coolant leakage and electrical short-circuits. Users must stop using the device immediately and follow recall instructions.
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the Allura Xper FD10F, Model Number 722002. It was distributed worldwide, including the US and multiple countries. This recall affects 12 units.
If the drip tray is not installed, coolant could contact electrical components, leading to electrical short-circuits. This issue may trigger system fuses and cause the system to shut down.
No incidents or injuries have been reported related to this recall. However, the potential hazard is classified as high.
Stop using the Allura Xper FD10F immediately. Contact Philips Medical Systems or your healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1063-2026. Patients should also reach out to Philips Medical Systems Nederland B.V.
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